Merck Head of Pharmacovigilance Operations- #NCP1 in Kenilworth, New Jersey
The AVP of Pharmacovigilance (PV) Operations is a global executive role that provides leadership in the areas of PV Operations, medical assessment, compliance, business capabilities, and innovation. The incumbent also oversees functional strategy planning and ensures effective development, implementation and execution of processes and standards to ensure patient safety. The AVP is accountable for activities pertaining to existing and evolving global regulations for the collection, processing, medical assessment and reporting of PV information to regulatory agencies and business partners. This role is responsible for providing leadership to the teams which support the end-to-end business processes for global PV activities and working cross-functionally to maintain standards for pharmacovigilance activities to ensure patient safety.
Reports to the R&D Strategic Operations VP
Resources Managed (FTEs)
Approximately 21 FTEs
Team members located at US, Switzerland and Singapore
AVP of PV Operations will manage the following direct reports:
PV Quality and Compliance Management Executive Director
Medical Safety Review and Device Reporting Executive Director
Regional PV Operations Executive Director
US PV Director
PV Process and Standards Director
Create a compelling vision and strategy for the safety operations organization that energizes and motivates the team to aspire to excellence.
Create and maintain a culture of quality, compliance, and operational excellence that drives toward the highest level of quality and compliance for individual case and aggregate safety reporting in accordance with PV regulations to meet the needs of key stakeholders internally and externally.
Drive policy related to pharmacovigilance by combining a broad knowledge of PV regulations with an equally broad knowledge of functional areas within the company.
Establish a high performing case medical assessment and device reporting capability.
Represent the organization in key external discussions to shape global regulatory and safety science for the entire industry.
Responsible for responses to regulatory agency questions with regards to pharmacovigilance activities
Provide sponsorship and leadership to various important pharmacovigilance process, IT and quality initiatives.
Drive innovation in the safety system and business process space in partnership with IT, external IT vendors, and business process outsourcing organizations.
Define and monitor key performance indicators and ensure implementation of corrective and preventative actions as appropriate.
Build a team of leaders that can represent the company during regulatory inspections and that removes the dependency on one individual to successfully navigate an inspection.
Continual analysis of business processes to ensure minimization of compliance risk, optimal efficiency and maximization of business resources
Define strategic and forward-thinking approach to achieve global consistency of individual and aggregate report activities
Resolve complex technical, operational and financial problems
Maintain strong vendor relationships to ensure optimal performance and compliance with local and global PV regulations
Communicate potential safety issues to the Chief Safety Officer Partner across strategic operations to drive quality, compliance, and operational excellence into critical interfaces in R&D, Commercial, and Manufacturing.
Participate in Audits/inspections as subject matter expert for PV organization
Master's degree in health care/pharmaceutical related field or M.D. /D.O. / PhD or equivalent Ex US degree in Medicine
Preferred: Medical or relevant advanced degree
Minimum of 15 years of experience in the pharmaceutical industry with a specific focus on pharmacovigilance related activities
Minimum of 7 - 10 years of experience supervising/managing/leading
Organizational leadership skills in working with all levels of management and consulting with key business stakeholders
Demonstrated ability to innovate and drive successful transformational change in the PV space
Strong understanding of end to end pharmacovigilance processes related to individual case and aggregate safety reporting
Exceptional understanding and knowledge of individual case medical review and device reportability requirements.
Knowledge of global AE reporting requirements and relevant PV regulations
Regulatory Agency inspection experience
Proven enterprise leadership that goes beyond PV and R&D
Experience working cross culturally and actively supporting diversity
Problem solving, conflict resolution and critical thinking skills
Excellent presentation, writing and communication skills
US and Puerto Rico Residents Only:
If you need an accommodation for the application process please email us at [email protected]
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OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf
We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
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Flexible Work Arrangements:
Valid Driving License:
Number of Openings:
Requisition ID: R61028
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